Breakthrough status for Allergan's antidepressant

Allergan’s experimental drug rapastinel has picked up a breakthrough therapy award in the US as an adjunctive treatment for major depressive disorder.

Rapastinel (formerly known as GLYX-13) is an investigational intravenous formulation of a novel NMDA receptor partial agonist which, the firm says, has shown a rapid onset of antidepressant efficacy one day after a single dose in a Phase II clinical trial of patients with MDD who had an inadequate response other antidepressants.

Around 16 million people in the US are living with MDD and despite available therapies, there remains an unmet need for agents that demonstrate a rapid onset of action, said David Nicholson, president of Global R&D brands at Allergan. “We believe that rapastinel has great potential to fulfill that unmet medical need in major depressive disorder."

"Nonresponse to antidepressants is a key reason that major depressive disorder is one of the United States' leading public health problems and there is a great need for new therapies that are truly different from those that are currently used," noted Michael Thase, Professor of Psychiatry at the Perelman School of Medicine of the University of Pennsylvania.

"Rapastinel (GLYX-13) thus has great promise because it works through a different pathway than conventional antidepressants and may even work faster than standard therapies."

A series of Phase III registration trials for the drug, which also carries fast-track status in the US, are planned to begin in 2016.